Prostate Cancer Clinical Trial

A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors

Summary

Study CP-MGC018-03 is a randomized, open-label, seamless, Phase 2/3 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.

The Phase 2 stage will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg Q4W and 2.7 mg/kg Q4W) compared to the control arm (abiraterone or enzalutamide). Approximately 150 participants will be randomized 1:1:1 in Phase 2 among the three study treatment arms (two vobramitamab duocarmazine experimental arms and one control arm). An interim analysis will be performed to select the Phase 3 dose regimen for the vobramitamab duocarmazine experimental arm for Phase 3 after approximately 150 participants enrolled in Phase 2 have been followed for at least 2 months (60 days).

The Phase 3 stage will assess efficacy of the selected dose regimen for the vobramitamab duocarmazine experimental arm versus the control arm (abiraterone or enzalutamide). Approximately 270 additional participants will be randomized 1:1 between each study treatment arm in Phase 3 (one vobramitamab duocarmazine experimental arm and the control arm).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Part 1 only: Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
Part 2 only: Histologically confirmed SCC or the anus, melanoma, HNSCC, squamous NSCLC, or SCLC.
Part 1 only: Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of <60 days used as bridging to lutetium-177 is permitted.
Part 2 only: At least 1 prior line of systemic therapy for unresectable or metastatic disease and no more than 2 prior lines of cytotoxic chemotherapy. Participants with HNSCC or melanoma must have received prior PD-1 or PD-L1 inhibitor for advanced or metastatic disease.
All participants must have ≥ 1 metastatic lesion, according to RECIST 1.1 or PCWG3 criteria, that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
All participants must have tumor progression, according to disease-specific criteria, following their most recent anti-cancer therapy.
All participants must have and available archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
All participants have acceptable physical condition and laboratory values.
All participants of childbearing potential must agree to use highly effective methods of birth control.
All participants must not be pregnant, planning to be pregnant, or breastfeeding.

Exclusion Criteria:

Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
Part 1 only: Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of <60 days used as bridging for lutetium-177 is permitted.
Part 1 only: Received >3 total prior therapies for mCRPC
Part 1 only: Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
Untreated, symptomatic central nervous system (CNS) metastasis.
Prior treatment with any B7-H3 targeted agent for cancer,
Contradictions to the use of corticosteroid treatment
Prior stem cell, tissue, or solid organ transplant.
Part 1 only: Use of products that have published anti-prostate cancer activity or are known to decrease PSA.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

382

Study ID:

NCT05551117

Recruitment Status:

Active, not recruiting

Sponsor:

MacroGenics

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There are 61 Locations for this study

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Compassionate Cancer Care Medical Group
Fountain Valley California, 92708, United States
University of California Los Angeles (UCLA) Community Cancer Care
Los Angeles California, 90095, United States
The University of Florida Health System - UF Health Urology - Jacksonville
Jacksonville Florida, 32209, United States
Mid Florida Hematology and Oncology Center
Orange City Florida, 32763, United States
Pontchartrain Cancer Center
Covington Louisiana, 70433, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Barbara Ann Karmanos Cancer Institute - Hudson-Webber Cancer Research Center
Detroit Michigan, 48201, United States
Masonic Cancer Center, University of Minnesota
Minneapolis Minnesota, 55455, United States
Gabrail Cancer Center
Canton Ohio, 44718, United States
VA Portland Health Care Services
Portland Oregon, 97239, United States
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States
University of Virginia Comprehensive Cancer Center
Charlottesville Virginia, 22908, United States
Virginia Cancer Specalists
Fairfax Virginia, 22031, United States
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States
Ramsay Health Care - Westmead Private Hospital
Westmead New South Wales, 2145, Australia
The University of Queensland (UQ) - Princess Alexandra Hospital (PAH)
Woolloongabba Queensland, 4102, Australia
Cabrini Health- Malvern
Malvern Victoria, 3144, Australia
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia
Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert Brussles, 1200, Belgium
(Grand Hopital de Charleroi) GHDC
Charleroi Hainaut, 6000, Belgium
Centre Hospitalier de Ardenne - Libramont - Clinique du Sein
Libramont Luxembourg, 6800, Belgium
Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)
Godinne Namur, 5300, Belgium
Algemeen Ziekenhuis Maria Middelares
Gent , 9000, Belgium
Centre Antoine-Lacassagne
Nice Cedex 2 AM, 06189, France
Institut de Cancerologie Strasbourg Europe (ICANS)
Strasbourg Bas Rhin, 67200, France
Institut Bergonié
Bordeaux Gironde, 33076, France
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier Herault, 34298, France
Hôpital d'Instruction des Armées Bégin
Saint-Mandé Ile De France, 94160, France
Hopital Foch
Suresnes Ile De France, 92150, France
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire Ille Et Vilaine, 35760, France
Clinique Victor Hugo
Le Mans Sarthe, 72000, France
Gustave Roussy
Villejuif Val De Marne, 94800, France
CHRU Brest
Brest , 29200, France
Institut Mutualiste Montsouris
Paris , 75014, France
AOU San Luigi Gonzaga Oncology Department
Orbassano TO, 10049, Italy
Ospedale dell'Angelo
Mestre Venice, 30174, Italy
Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence
Florence , 50134, Italy
Istituto Oncologico Veneto
Padova , 35128, Italy
Azienda Provinciale per i Servizi Sanitari - Presidio Ospedaliero S. Chiara
Trento , 38122, Italy
Kyungpook National University Chilgok Hospital
Bugok Daegu, 41404, Korea, Republic of
National Cancer Center
Goyang Kyonggi, 10408, Korea, Republic of
Chonnam National University Hospital
Gwangju , 61469, Korea, Republic of
Seoul National University Hopital
Seoul , 03080, Korea, Republic of
Yonsei University Health System, Severance Hospital
Seoul , 03722, Korea, Republic of
Samsung Meical Cemter
Seoul , 06351, Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul , 07985, Korea, Republic of
Asan Medical Center
Seoul , 5505, Korea, Republic of
Szpital im. Fryderyka Chopina
Otwock Mazowieckie, 05-40, Poland
Magodent Szpital Elblaska
Warszawa Mazowieckie, 01-74, Poland
Medical Concierge Centrum Medyczne
Warszawa Mazowieckie, 02-79, Poland
Grochowski Hospital
Warszawa Mazowieckie, 04-07, Poland
Przychodnia Lekarska "KOMED"
Konin Wlkp, 62-50, Poland
Szpital Wojewodzki im. Mikolaja Kopernika
Koszalin Zachodniopomorskie, 75-58, Poland
Hospital Universitari Parc Taulí
Sabadell Barcelona, 08208, Spain
Hospital Universitario Virgen del Rocio
Sevilla Seville, 41013, Spain
Hospital Del Mar
Barcelona , 08003, Spain
Hospital Clinic de Barcelona
Barcelona , 08036, Spain
Hospital de la Santa Creu I Sant Pau
Barcelona , 08036, Spain
Hospital Universitario Lucus Augusti
Lugo , 27002, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
The Royal Marsden NHS Trust
Sutton Surrey, SM2 5, United Kingdom
Oxford University Hospitals NHS- Churchill Hospital
Oxford , OX3 7, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

382

Study ID:

NCT05551117

Recruitment Status:

Active, not recruiting

Sponsor:


MacroGenics

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